Time is an extremely precious commodity for drug companies. Drug development is a complex process that involves high expenses and takes up to 14 years. Pharma players try their best to introduce a new drug to the market as soon as possible and make a profit before the 20-year patent protection expires and generic rivals join the race.

Workflow Management

Drug inventors might face different challenges: unsuccessful trials, clinical holds, regulatory and compliance issues. Still, such a big hurdle as poor workflow management tend to be underestimated or even ignored. Being built properly, a workflow management system has the potential to accelerate the whole drug development process.

Managers running a drug development project often lack clear visibility of tasks performed by researchers. In this case managers may fail to ensure an efficient resource allocation, which will lead to unexpected expenses and productivity losses.

A well-developed workflow management system can become an important tool for controlling the entire clinical trial: different workflows will be clearly defined, and all the tasks will be assigned to relevant staff members, thus maximizing chances of developing the product at a faster rate.

Features of a Successful Workflow Management System

What does a successful workflow management system for clinical research look like? Here are crucial features it must have:

• Reassigning capabilities. Managers should always be able to re-assign users to other tasks or remove tasks if needed.
• Mobility. People should get access to the system at any time from any device.
• Notifications. Email and push notifications will help managers to keep team members engaged by informing them about the latest changes.
• Role-based access control. Employees have different responsibilities and tasks. So, it’s essential that the system has different access levels.
• KPI-based reporting. This feature is indispensable since it produces complete reports that detail the progress, identify areas of concern, etc. Managers can use these reports to promptly respond to any difficulty that may arise (e.g. trials not matching expectations) and plan further actions.
• SLA status reporting. These reports show if all the SLA policies are met by different teams and individual users.

Document Management

Effective document management is one more critical issue, as bad practices may cause serious delays. Let’s briefly see how documents are produced at different stages of drug development.

• Discovery and Development Stage

Healthcare players (pharmacologists and chemists) conduct clinical trials including a lot of tests of molecular compounds, trials of existing and new treatments, and more. The collected data take the form of notes, reports and other documentation.

• Preclinical and Clinical Research

At these stages researchers devote all their effort to test the drug’s safety, efficacy, side effects, and adverse reactions.

Though the preclinical research doesn’t take much time, clinical studies may last for 10 years or more. Many pharma companies opt for contract research organizations (CROs) in order to speed up research.

Cross-functional teams that include researchers, CROs, hospital staff, and other parties (e.g. sponsors) produce a plethora of documents. But very few pharma companies boast a well-organized document management process.

Approach to Data Storage

Organizations taking part in clinical trials usually store information related to the trial in the form of trial master files (TMFs). Companies today make use of electronic TMF (eTMF) applications. These tools help them be better prepared for inspections by reducing the number of duplicate documents, incomplete files, etc.

TMFs can be managed passively (using local file systems and cloud file shares) or actively (with the help of purpose-built eTMFs). The passive model is appropriate when there is no need to share information with many teams based in different locations.

Users of the active model benefit a lot from managing files in real-time, therefore passive management is now becoming less popular. Some other benefits of eTMF systems are unlimited roles, robust access control, and electronic notifications, to name but a few. E-signatures are one of the biggest advantages of active eTMFs. Today they are accepted by leading regulatory agencies, which in turn removes the need for wet signatures.

CROs work with many applications. They integrate eTMF solutions with third-party software (e.g. EDC systems). And this integration helps such organizations efficiently manage all research-related activities and content.

Conclusion

Drug development is a challenging undertaking that requires much time and effort. To eliminate potential delays and additional expenses pharma companies and CROs apply workflow management systems and eTMF solutions to accelerate their activities. It’s also crucial to choose the right provider of medical software with appropriate expertise in the healthcare domain.